NCT01683266已完成3 期
A 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Injected in the Morning or Evening in Patients With Type 1 Diabetes Mellitus With a 6-month Safety Extension Period
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 549
- 试验地点
- 147
- 主要终点
- Change In HbA1c From Baseline to Month 6 Endpoint
研究概览
简要总结
Primary Objective:
- To compare the efficacy of a new formulation of insulin glargine and Lantus (overall, regardless the injection time) in terms of change of HbA1c from baseline to endpoint (scheduled Month 6) in participants with type 1 diabetes mellitus
Secondary Objective:
- To compare HOE901-U300 and Lantus when given in the morning or in the evening in terms of:
- Change of HbA1c from baseline to endpoint (scheduled Month 6)
- Change from baseline to endpoint (Month 6) in fasting plasma glucose (FPG), plasma glucose prior to injection of study drug, plasma glucose at 03:00 hours, mean plasma glucose (8-point profiles), glucose variability, treatment satisfaction and health related quality of life in participants with Type 1 Diabetes Mellitus (T1DM)
- Reaching target HbA1c values and controlled plasma glucose (all and reaching target without hypoglycemia)
- Frequency of occurrence and diurnal distribution of hypoglycemia by category of hypoglycemia (symptomatic, asymptomatic, nocturnal, severe, probable and relative)
- Safety and tolerability of HOE901-U300 including development of anti-insulin antibody (AIAs) during the 12-month study period
详细描述
The maximum study duration was up to approximately 54 weeks per participants:
- Up to 2-week screening period
- 6-month open-label comparative efficacy and safety treatment period
- 6-month open-label comparative safety extension period
- 48-hour post-treatment safety follow-up period
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
HOE901-U300
Experimental
HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily in morning or evening for 12 months on top of mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter [mg/dL]).
干预措施: HOE901-U300 (Insulin glargine new formulation) (Drug)
Lantus
Active Comparator
Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning or evening for 12 months on top of mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).
干预措施: Lantus (Insulin glargine) (Drug)
结局指标
主要结局
Change In HbA1c From Baseline to Month 6 Endpoint
时间窗: Baseline, Month 6
次要结局
- Percentage of Participants With FPG <7.2 mmol/L (130 mg/dL) at Month 6 Endpoint(Month 6)
- Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint(Baseline, Month 6)
- Change in Variability of Pre-injection SMPG From Baseline to Month 6 Endpoint(Baseline, Month 6)
- Percentage of Participants With Fasting Plasma Glucose (FPG) <5.6 mmol/L (100 mg/dL) At Month 6(Month 6)
- Change In Average Pre-Injection Self-Monitored Plasma Glucose (SMPG) From Baseline Month 6 Endpoint(Baseline, Month 6)
- Change in Fasting Plasma Glucose From Baseline to Month 6 Endpoint(Baseline, Month 6)
- Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint(Baseline, Month 6)
- Change in Daily Average Total Insulin Dose From Baseline to Month 6 Endpoint(Baseline, Month 6)
- Percentage of Participants With HbA1c <7% at Month 6 Endpoint(Month 6)
- Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12(Up to Month 12)
- Percentage of Participants With HbA1c Less Than or Equal to 6.5% at Month 6 Endpoint(Month 6)
研究者
研究点 (147)
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